お忙しい中、回答を頂き感謝します。
しかし、もう少し疑問が残っています。
１）確認試験について今までNIR,IR,TLCの3つの試験で実施していたとい認識でいいのか。NIRを実施しない理由ならびにアーカイブされた理由を教えてください。
２）試薬で登録している貴社の意見も十分理解ですますが、ベンズアルデヒドは出発物質として記載するとのPMDAの指示なので、その指示に従ってください。
Thank you for your reply despite your busy schedule.
However, I still have a few questions.
1) In regards to the confirmation examination, is it verified that these three examinations (NIR, IR and TLC) have been carried out up to now? If the NIR examination was not carried out, can you tell me the reason that was given and recorded?
2) I understand your company's opinion regarding the trial medicine that has been registered. However, as PMDA instructs that benzaldehyde be listed as a starting ingredient, so follow that instruction.
